Job Title: Senior Manager, Clinical Affairs
Supervisor/Manager Title: Director, Clinical Affairs
Job Description Summary: The Sr. Manager, Clinical Affairs will serve as the Study Manager responsible for developing and conducting global clinical trials/studies on JenaValve products and for ensuring compliance with US Food and Drug Administration (FDA) regulations, international regulatory standards, and other regulations as applicable. He/She leads and manages the activities of Clinical Affairs department, as well as external vendors (e.g., clinical research organizations (CROs), regional monitors, and consultants). The Sr. Manager, Clinical Affairs works as a part of the Clinical Affairs Leadership team to accomplish department objectives by managing assignments, planning, and evaluating department projects. This position provides leadership and support to members of multidisciplinary project teams, both internally and externally, and provides guidance to assigned Clinical Affairs personnel collaborating closely with other JenaValve departments (Regulatory Affairs, R&D, Professional Education, Finance, Quality Assurance, etc.)
Job Responsibilities:
Drive strategic operational management of JenaValve pre- and post-market portfolio of clinical studies with attention to improving efficient execution of review and approval processes, contracting, correspondence with study sites, developing supporting clinical documents (e.g., IRB/ethics committee submission requirements), site initiation coordination, tracking enrollments, facilitating analyses, and reporting of results.
Maintain a close collaboration with Clinical Data Management, Biostatistics, Monitoring, and Regulatory Affairs departments to ensure goals and objectives of the clinical operations program are met and timelines for study completion, data cleaning, analysis, regulatory submissions, and publication of study results are achieved in a timely manner.
Accountable for study implementation and execution of clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives.
Ensures JenaValve compliance with Clinical SOPs and GCP/ICH guidelines and supports the development of new and periodic revision of JenaValve Clinical SOPs.
Manages the development and review of relevant study-specific documents, including study protocols, informed consents, progress reports, data snapshots, and clinical study reports.
Develop and manage additional study-specific materials, such as, training presentations, PMA project plan(s), Monitoring Plan, Study Logs, CRFs, CRF Completion Guidelines, Source Documents, Reference Guides, and Newsletters.
Ensures operational and regulatory integrity of studies and participates in FDA or other regulatory authority inspections.
Ensure that internal project team members are trained appropriately on proper study conduct and all business processes.
Manage relationships with consultants to provide adequate support and services for data collection and analysis.
Participates in the development/management of study budgets and contributes to the clinical study site selection and clinical vendor selection processes.
Support in the recruitment, training, and support Clinical Affairs staff, which may include Clinical Research Associates and Clinical Coordinators.
Travel up to 15%
Required Education and Experience:
8-10+ years of experience in clinical trial research is required (preferred in medical devices).
5+ years of experience with CTMS, EDC, eTMF, and in end-to-end clinical trial activities; including feasibility, start-up, study conduct, close-out, data review, and report writing of clinical studies.
Advanced degree in a biological science / pharmacy/ nursing desired.
Skills and Abilities Required for This Job:
Working knowledge of the FDA submission process; including IDE, PMA, and 510(k) preferred.
Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device directive 93/42/EEC, ISO14155 and ICH Guidelines.
Experience in developing SOPs and clinical operations metrics.
Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.
Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work.
Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.
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